Evidence map›Paper›PMID 33052555›Full record

ArticleEndocrine2021

Lanreotide autogel/depot in advanced enteropancreatic neuroendocrine tumours: final results of the CLARINET open-label extension study.

Martyn E Caplin, Marianne Pavel, Alexandria T Phan, Jarosław B Ćwikła, Eva Sedláčková, Xuan-Mai Truong Thanh, Edward M Wolin, Philippe Ruszniewski, CLARINET Investigators

2 registry-linked trialsOpen access · hybridAbstract read
In one paragraph

Article in Endocrine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 48 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
48citing papers in PubMed, 1 pooled it
4.9field-weighted citation impact, top 4% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00353496 phase3completednot on this map

Phase III, Randomised, Double-blind, Stratified Comparative, Placebo Controlled, Parallel Group, Multi-centre Study to Assess the Effect of Deep Subcutaneous Injections of Lanreotide Autogel 120mg Administered Every 28 Days on Tumour Progression Free Survival in Patients With Non-functioning Entero-pancreatic Endocrine Tumour

TypeinterventionalSponsorIpsenRan2006 to 2013Enrolled264ConditionsEndocrine TumorsArmslanreotide (Autogel formulation), Placebo
NCT00842348 phase3completednot on this map

Open Label Extension Study of Lanreotide Autogel 120 mg in Patients With Non-functioning Entero-pancreatic Endocrine Tumour

TypeinterventionalSponsorIpsenRan2009 to 2015Enrolled89ConditionsNon Functioning Entero-pancreatic Endocrine TumourArmslanreotide (Autogel formulation)
3 · Its place in the literature

Who cites it

48 citing papers in PubMed, 1 synthesis or guideline pooled it, 79 citations in OpenAlex.

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  15. Long-term experience with octreotide and lanreotide for the treatment of gastroenteropancreatic neuroendocrine tumors.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2025
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 8 institutions in 6 countries.

Martyn E CaplinDepartment of Gastroenterology and Tumour Neuroendocrinology, Royal Free Hospital, London, UK. m.caplin@ucl.ac.uk.
Marianne PavelDepartment of Medicine, Division of Endocrinology and Diabetology, Universitätsklinikum Erlangen, Friedrich Alexander University Erlangen-Nürnberg, Erlangen, Germany.
Alexandria T PhanDepartment of Hematology-Oncology, University of Texas Health Science Center at Tyler, Tyler, TX, USA.
Jarosław B ĆwikłaDepartment of Cardiology and Cardiac Surgery, School of Medicine, University of Warmia and Mazury, Olsztyn, Poland.
Eva SedláčkováDepartment of Oncology, First Faculty of Medicine and General Teaching Hospital, Prague, Czech Republic.
Xuan-Mai Truong ThanhMedical Affairs, Ipsen Pharma, Boulogne-Billancourt, France.
Edward M WolinTisch Cancer Institute at Mount Sinai and Icahn School of Medicine at Mount Sinai, New York, NY, USA.
Philippe RuszniewskiDivision of Gastroenterology and Pancreatology, Beaujon Hospital, Clichy, France.
CLARINET Investigators
Friedrich-Alexander-Universität Erlangen-Nürnberg · DEGeneral University Hospital in Prague · CZHôpital Beaujon · FRIcahn School of Medicine at Mount Sinai · USIpsen (France) · FRThe Royal Free Hospital · GBThe University of Texas Health Science Center at Tyler · USUniversity of Warmia and Mazury in Olsztyn · PL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeIn the phase III CLARINET study (NCT00353496), lanreotide autogel/depot (lanreotide) significantly improved progression-free survival (PFS) vs placebo in patients with non-functioning intestinal or pancreatic neuroendocrine tumours (NETs). The aim of CLARINET open-label extension (OLE) (NCT00842348) was to evaluate long-term safety and efficacy of lanreotide in these patients.

methodsPatients from the CLARINET study were eligible for the OLE if they had stable disease (irrespective of treatment group) or progressive disease (PD) (placebo-treated patients only). All patients in the OLE received lanreotide 120 mg every 28 days. Computed tomography or magnetic resonance imaging scans were conducted every 6 months and assessed locally for PD (the final scan was also assessed centrally).

resultsOverall, 89 patients took part in the OLE (lanreotide, n = 42; placebo, n = 47). Median (range) exposure to lanreotide in patients who received lanreotide in the core study and OLE (LAN-LAN group) was 59.0 (26.0-102.3) months. In this group, the overall incidences of adverse events (AEs) and treatment-related AEs were lower in the OLE than in the core study. Median [95% CI] PFS in the LAN-LAN group was 38.5 [30.9; 59.4] months. In placebo-treated patients with PD at the end of the core study, time to death or subsequent PD during the OLE was 19 [10.1; 26.7] months.

conclusionsThis study provides new evidence on the long-term safety profile and sustained anti-tumour effects of lanreotide autogel/depot in indolent and progressive metastatic intestinal or pancreatic NETs.

Indexed as

Antineoplastic AgentsNeuroendocrine TumorsPancreatic NeoplasmsHumansPeptides, CyclicSomatostatinAntineoplastic AgentslanreotidePeptides, CyclicSomatostatinLanreotide autogelLanreotide depotNeuroendocrine tumoursProgression-free survivalSafety

Identifiers

PMID33052555
PMCPMC7881960
OpenAlexW3092115967

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.